FDA Product Code BTM: Ventilator, Emergency, Manual (resuscitator)
Leading manufacturers include Compact Medical, Inc. and Laerdal Medical AS.
FDA 510(k) Cleared Ventilator, Emergency, Manual (resuscitator) Devices (Product Code BTM)
About Product Code BTM - Regulatory Context
510(k) Submission Activity
209 total 510(k) submissions under product code BTM since 1976, with 209 receiving FDA clearance (average review time: 124 days).
Submission volume has remained relatively stable over the observed period, with 2 submissions in the last 24 months.
FDA Review Time
Recent submissions under BTM have taken an average of 155 days to reach a decision - up from 123 days historically. Manufacturers should account for longer review timelines in current project planning.
BTM devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →